Clin2
NCT04333537Possibly a fitRecruiting

Sentinel node biopsy versus standard neck surgery for early mouth cancer

Buccal Mucosa Squamous Cell CarcinomaFloor of Mouth Squamous Cell CarcinomaGingival Squamous Cell CarcinomaHard Palate Squamous Cell CarcinomaLip Squamous Cell CarcinomaLower Alveolar Ridge Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaRetromolar Trigone Squamous Cell Carcinoma

Part of Cancer, Mouth & dental clinical trials.

This trial compares two ways of checking whether early oral cavity squamous cell cancer has spread to neck lymph nodes. It tests whether sentinel lymph node biopsy can find spread as well as standard neck dissection, while potentially reducing more extensive surgery for some people.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
686 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have a confirmed squamous cell cancer in the mouth area (like tongue, floor of mouth, gum area, or hard palate).
  • Your cancer stage is early: T1–2, no known lymph nodes (N0), and no distant spread (M0).
  • You must be healthy enough for surgery (surgeon says you can safely have sentinel lymph node biopsy, with possible follow-up neck surgery).
  • You need recent scans showing no spread, including imaging of the head/neck within 42 days and a chest scan within 42 days.
  • Before randomization, you must do an FDG PET/CT scan of the body, and complete an English-or-French questionnaire (NDII).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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